Questions and Answers

Q. I’m doing a study that was approved last summer (under the “original” Common Rule). After reading your newsletter, I’m sure that this study doesn’t need to do Status Reports under the revised Common Rule. Can I just ignore the Continuing Review reminder that the Zipline system will email me next summer?

A. No. The revised Common Rule won’t be automatically applied to all previously-approved studies. You should still submit your Status Report next summer. But you can ask HSD at that time to assess your study for switching it to the revised Common Rule. We’ll let you know whether it makes sense for your study and whether it would involve any extra work for you to switch it (such as adding the new elements to your consent forms). If you ignore the Zipline reminder notice, your IRB approval will lapse and you will have to stop doing your study until you get it renewed.

Q. I’m still confused about whether I need to include the new consent elements in the consent form for the study you want me to send to WIRB for review instead of the UW IRB.

A. If your study is federally funded, you need to include the new consent requirements of the revised Common Rule, regardless of which IRB is doing the review unless the IRB grants a waiver to exclude one or more of the new elements.

Q. I’m doing a study that the UW IRB reviewed and approved last year. After reading your newsletter, I can tell that it would qualify for exempt status if it was reviewed under the revised Common Rule. Can I stop my study, re-apply so I get exempt status, and then start again?

A. Yes, you could, but you would be doing lots of unnecessary work. HSD will have a formal process for “switching over” already-approved studies to the revised Common Rule. It will not require a new application for studies like yours that were IRB-approved and will now qualify for exempt status. Stay tuned for details in an upcoming issue before January 21st.

Q. I read in one of your newsletters about the new requirement for clinical trials to post an unsigned copy of the study consent form in a public database like ClinicalTrials.gov. Why couldn’t I find anything about this at the ClinicalTrials.gov website?

A. The federal agency that manages the ClinicalTrials.gov website is still developing the instructions and informational materials about this requirement. No timeline for release has been provided. However, it is unlikely you will need to post your consent form before mid-2019 because:

This affects only clinical trials that are approved on or after January 21, 2019.

The consent form should not be posted until the trial closes to recruitment.

Q. One of the new required consent elements is to inform subjects if the study might include whole genome sequencing. Can you clarify whether the whole genome sequencing this refers to is of HUMAN genomes? For example, I have a study where we are collecting bacteria from human biospecimens and then doing whole genome sequencing of the bacteria. Would that need to be included in the consent form?

A. The requirement is only for sequencing of human genomes, so it doesn’t apply to the procedure you describe. You could still describe this part of your research in the consent form, but it would be as part of your general description of the study’s purpose and procedures, not because of this new specific requirement. This is how the requirement is written in the regulations:

“For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).”

Q. Thank you for releasing the revised consent template, so I have time to figure it out. But most of the IRB applications I prepare for my PI are for industry-funded studies that are reviewed by WIRB instead of the UW IRB, and they use a different consent template. Will the UW/WIRB template be updated soon or should we just incorporate any new elements as appropriate?

A. WIRB is a large commercial IRB that has historically reviewed most industry-funded studies conducted at the UW. It’s one way HSD conserves the UW IRB resources for the benefit of our faculty and students.

We have not revised the UW/WIRB consent template and will retire it within a few months because:

Commercial IRBs generally prefer that PIs use the template prepared by the company sponsor (for example, a drug company).

We’ve found that the UW/WIRB template has been confusing and cumbersome for some research teams when they are trying to harmonize the sponsor’s template with ours.

We have just expanded our list of which commercial IRBs can be used for UW studies, to include Advarra (see the 11.5.18 edition of our regular eNewsletter “For the Record”.) We may add others soon. It is not feasible to maintain separate consent templates for each of the commercial IRBs.

Q. Yesterday I submitted a new IRB application that I know involves more that minimal risk and so it will need to be reviewed by the full IRB committee. I submitted it after the October 15th date on your Common Rule timeline at the bottom of your newsletter. Does that mean my study is going to have to comply with all the requirements of the revised Common Rule?

A. Not necessarily. The original Common Rule will apply to your study if the IRB can grant approval or MRSA (Modifications Required to Secure Approval) status to your study before January 21, 2019. if not, then you will need to comply with the revised Common Rule.

HSD and the IRBs will work hard to complete as many reviews as possible before January 21st, regardless of when you submit your application – but be aware this is our most challenging time of year because of holidays, staff and IRB member vacations, and IRB member absences between fall and winter quarters.

The October 15 and December 15 dates are guidelines, not deadlines or promises.

Q. I’m confused about why HSD has already released a revised consent template and is encouraging researchers to use it right away, before January 21, 2019. Why make us do the extra work of including the new elements and the Key Information, if we don’t have to?

A. Including the new required consent elements and key information in your consent materials is required only if you think your initial IRB application is likely to be approved (or conditionally approved) on or after January 21, 2019. If your application is likely to be approved prior to January 21, you can choose to leave out the new requirements. However, they are widely considered to be best practices that will provide important information to potential participants. Finally, we want researchers to have plenty of time to consider the new requirements and to ask HSD questions about them. This will help us develop or improve the consent template and accompanying guidance.

Q. I have a UW IRB approval for a study I’m doing now. I’ll still be enrolling and consenting subjects after January 21, 2019. Will I need to (1) Submit a modification for my consent form, to add the new required elements, and (2) use the modified consent form for all new subjects after January 21st, and/or (3) re-consent the subjects that I consented before January 21st who are still participating in the study after January 21st?

A. No, to all parts of your question. Your study was approved under the original Common Rule and it continues to be governed by that version of the Common Rule even after January 21st. Sometime in the future, you and the IRB might mutually decide it would be advantageous to switch over your study from the original Common Rule to the revised Common Rule. If you are still enrolling and consenting subjects at that time, then you will need to modify your consent form to include the new elements and you will need to use the modified consent form with any new subjects.

Q. I’ve heard that the definition of human subjects research doesn’t change in the revised Common Rule, but I’ve also heard that many more studies will now qualify for exemption. How can that be true? Doesn’t exemption (exempt status) mean that something isn’t human subjects research?

A. They are two different things. HSD makes human subjects research determinations for all initial applications, to assess whether your planned activity meets the regulatory definition of “research” or “human subject”. If it doesn’t, you don’t need IRB review. If it does meet the definition, then HSD makes an exempt determination to assess whether your research qualifies for exempt status. Exempt status means that your activity IS human subjects research but that it is not required to comply with the Common Rule because it involves very little risk to the research participants.

Q. I thought the revised Common Rule was going to define all biospecimens as “human subjects”, even when they are de-identified or anonymous (because of the Henrietta Lacks scandal). What happened? And aren’t biospecimens basically identifiable anyway no matter what, because they contain unique DNA?

A. The first draft of the revised Common Rule did indeed propose that all biospecimens should be treated as if they were inherently identifiable. This proposal received strong negative reactions during the public comment period, so it was dropped from the final version of the revised Rule. Also, current technology and databases don’t provide a way to readily link up the DNA from a specimen with a specific person. However, the federal agencies recognized that technology and databases are rapidly evolving. So the final revised Common Rule requires the agencies to re-assess the definition of private identifiable information and the impact of analytic technologies and techniques every four years. (The Henrietta Lacks scandal is fascinating. See the book called the Immortal Life of Henrietta Lacks, by Rebecca Skloot.)

Q. I’ve heard that the original Common Rule will apply to my IRB application and my study as long as I get my application to HSD by January 21, 2019 (the implementation date of the revised Common Rule). Is that correct?

A. No. What matters is the status of your application on that January 21, 2019 date. The revised Common Rule and its new requirements will apply to all studies that have not received IRB approval prior to that date. Find your application status by looking at the purple box in the upper left corner of your study workspace in Zipline.

Q: Will I need to repeat my human subjects training when the revised Common Rule is implemented?

A: No. A few very specific details will become out-of-date. But the training will otherwise remain accurate and valid.